Alexander Spivak
- Role
- Staff Quality Engineer at Enable Injections, Inc.
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Alexander Spivak
Strategic Quality Engineering Manager with a passion for solving complex R&D challenges…
Experience
Staff Quality Engineer
Apr 2022 — Present
Continues expanding procedural standardization efforts for commercialization readiness. • Acts as the main Quality Engineer Design Reviewer for all Product Development projects. • Develops new Statistical Techniques for use across the company. • Provides technical responses for Government Regulatory Body inquiries.
Education
Sycamore High School
High School Diploma
2004 — 2008
University of Cincinnati
Bachelor of Science (B.S.), Biomedical/Medical Engineering
2008 — 2013
Skills
- Statistics
- Microsoft Office
- Quality System
- Lifesciences
- Technical Writing
- Regulatory Affairs
- Design Verification Testing
- Minitab
- Failure Mode and Effects Analysis (Fmea)
- Biotechnology
- Research
- R&D
- Project Management
- Quality Plans
- Molecular Biology
- Matlab
- Clinical Research
- Manufacturing
- Engineering
- Research and Development (R&D)
- Laboratory
- Data Management
- Risk Management
- Bioinformatics
- Solidworks
- Design Control
- Biomedical Engineering
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